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Clinical Trial Record

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Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer

2010-04-20

2024-07-17

2026-08

71

Study Overview

Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer

The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene (GVAX Pancreas Vaccine) alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas.

N/A

  • Pancreatic Cancer
  • DRUG: Cyclophosphamide
  • DRUG: Cyclophosphamide Pill
  • BIOLOGICAL: GVAX Pancreas Vaccine
  • J09100
  • NA_00031401 (OTHER Identifier) (OTHER: JHM IRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2010-03-01  

2025-06-17  

2025-08-06  

2010-03-16  

2025-06-17  

2025-08-26  

2010-03-17  

2025-07-03  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Cohort 1 (J0810 Arm A)

Patients coming from J0810 (NCT00727441). Patients receive GVAX.

BIOLOGICAL: GVAX Pancreas Vaccine

  • Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
EXPERIMENTAL: Cohort 1 (J0810 Arm B)

Patients coming from J0810 (NCT00727441). Patients receive IV CY and GVAX.

DRUG: Cyclophosphamide

  • Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days)

BIOLOGICAL: GVAX Pancreas Vaccine

  • Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
EXPERIMENTAL: Cohort 1 (J0810 Arm C)

Patients coming from J0810 (NCT00727441). Patients receive oral CY and GVAX.

DRUG: Cyclophosphamide Pill

  • Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).

BIOLOGICAL: GVAX Pancreas Vaccine

  • Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
EXPERIMENTAL: Cohort 2 (Vaccine Naive)

Patients receive IV CY and GVAX.

DRUG: Cyclophosphamide

  • Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days)

BIOLOGICAL: GVAX Pancreas Vaccine

  • Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
EXPERIMENTAL: Cohort 3 (J1568)

Patients coming from J1568 (NCT02451982). Patients receive IV CY and GVAX.

DRUG: Cyclophosphamide

  • Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days)

BIOLOGICAL: GVAX Pancreas Vaccine

  • Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
EXPERIMENTAL: Cohort 4 (J15237)

Patients coming from J15237 (NCT02648282). Patients receive IV CY and GVAX.

DRUG: Cyclophosphamide

  • Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days)

BIOLOGICAL: GVAX Pancreas Vaccine

  • Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
EXPERIMENTAL: Cohort 5 (J1766)

Patients coming from J1766 (NCT03153410). Patients receive IV CY and GVAX.

DRUG: Cyclophosphamide

  • Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days)

BIOLOGICAL: GVAX Pancreas Vaccine

  • Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment DiscontinuationSafety as measured by local and systemic toxicity according to NCI CTCAE v 3.0121 Months
Number of Participants Experiencing Grade 3 or Above Drug-Related Adverse Events (AEs)Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0121 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease Free Survival (DFS)DFS was measured as the time from date of surgery until pancreatic cancer recurrence or death. Disease status was monitored by radiologic scans done per standard of care. DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve.131 months
Overall Survival (OS)OS was measured as the amount of time from date of surgery until death or end of follow-up. OS was censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis. Estimation based on the Kaplan-Meier curve.174 Months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Has a history of surgically resected and pathologically proved AJCC stage I or stage II adenocarcinoma of the head, neck, or uncinate of the pancreas. 2. Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766. 3. Cohort 2: Have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and/or chemoradiation. 4. Cohorts 1, 3, 4 and 5: Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least 6-12 months prior. 5. Has received the last anti-cancer therapy at least 28 days ago. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Has provided informed consent. 8. Has adequate hematologic function.(Hemoglobin ≥ 9 g/dL ANC ≥ 1500/mm3 Platelets ≥ 100,000 K/ mm3). 9. Has adequate renal function (Serum creatinine ≤ 2 mg/dL). 10. Has adequate hepatic function. (Bilirubin ≤ 2.0 mg/dl, unless known Gilbert's Syndrome; AST, ALT and amylase ≤ 2x upper limit of normal, Alk Phos ≤ 5x upper limit of normal). 11. Agree to use adequate birth control, if of childbearing potential.
    Exclusion Criteria:
    1. Has radiographic evidence of pancreatic cancer recurrence. 2. Has any documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis,or vasculitis. 3. Has any uncontrolled medical problems. 4. Has had systemic steroid therapy within 28 days before vaccine administration. 5. Has an anticipated need for systemic steroid therapy within 28 days after vaccine administration. 6. Has any evidence of active infections. 7. Is pregnant. 8. Has a history of another cancer (other than pancreatic cancer) or myeloproliferative disorders in the past five years except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma in-situ of the cervix. 9. Has a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • The Skip Viragh Foundation
  • PRINCIPAL_INVESTIGATOR: Daniel Laheru, MD, Johns Hopkins University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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